QA Specialist I

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were not finished yet.

Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

Quality Assurance Specialist I

Everyone at Kite is grounded by one common goal curing cancer. Every single day we seek to establish a direct line between that purpose and our daytoday work. Would you like to join us in this mission

We are seeking a highly motivated individual to join us as a Quality Assurance Specialist I. In this role you will support activities of the Quality Assurance department within the Global QA organization supporting the Global Raw Materials and Reagents Center of Excellence (GRM&R CoE).

The Quality Assurance Specialist I is responsible for supporting compliance with the quality system identifying and assessing regulatory and quality risks and providing daytoday QA oversight of raw material and reagent processes within GRM&R.

Key Responsibilities (included but not limited to):

• Perform a wide variety of activities to ensure compliance with applicable quality objectives regulatory requirements and GMP guidelines

• Provide QA support through review and approval of raw material batch disposition records

• Review batchrelated documentation ensure resolution of issues and support timely release and shipment of raw materials

• Ensure approval and timely release of raw materials to the Global Network

• Verify and ensure timely issuance of production and testing documentation

• Ensure process control measures are in place and followed for raw material testing and provide guidance to laboratories on adherence to controls

• Provide document control support including issuance of testing forms for the site/laboratory and maintenance of electronic document organization and alignment

• Ensure all raw materialrelated deviations are initiated investigated and appropriate CAPAs are developed and completed

• Serve as Quality Approver on quality records including LIRs deviations and CAPAs

• Gather trend and report metrics to measure performance and support continuous improvement activities

• Identify and support continuous improvement initiatives within QA

• Ensure timely resolution and appropriate escalation of quality issues

• Participate in the development and maintenance of Standard Operating Procedures (SOPs) to ensure quality targets are met

• Participate in the development and execution of QA training activities

• Perform other duties as assigned

Basic Qualifications:

• Bachelors degree (BS) with a minimum of 2 years of relevant experience in a GMPregulated environment

• Associates degree (AA) with a minimum of 4 years of relevant experience in a GMPregulated environment

• Prior experience in the pharmaceutical or biotechnology industry is beneficial

Preferred Qualifications:

• Working knowledge of GMP requirements and ability to apply GMP principles in conformance with U.S. EU and RestofWorld regulations

• Experience supporting manufacturing or laboratory investigations deviations and CAPAs

• Strong interpersonal verbal and written communication skills

• Ability to collaborate effectively and build productive working relationships across teams

• Proficient in Microsoft Word Excel PowerPoint and other standard business applications

• Comfortable working in a fastpaced environment with the ability to adjust workload based on changing priorities

• Demonstrated organizational prioritization and timemanagement skills while managing multiple assignments

• Selfmotivated detailoriented and willing to take on temporary responsibilities outside of the initial job description

• Willingness to adapt best practices to evolving processes and business needs

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.